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Quality Assurance Auditor
| Dyddiad hysbysebu: | 25 Tachwedd 2024 |
|---|---|
| Oriau: | Llawn Amser |
| Dyddiad cau: | 25 Rhagfyr 2024 |
| Lleoliad: | Alderley Court, Larkwood, Tytherington Business Park Macclesfield, Cheshire SK10 2XR |
| Gweithio o bell: | Ar y safle yn unig |
| Cwmni: | Synexa Life Sciences |
| Math o swydd: | Parhaol |
| Cyfeirnod swydd: |
Crynodeb
Passionate about advancing healthcare? We provide bioanalytical services and we’re leading biomarker research to transform patient outcomes. Join our dynamic team and make a global impact. Explore exciting career opportunities with us today! Our brand-new facility has a wealth of state-of-the-art Scientific instruments, and we are based in Macclesfield in the heart of Cheshire.
We’re looking for a detail-oriented professional who can identify areas for improvement and support our compliance program, helping to uphold our commitment to excellence and innovation. With our rapid growth, this is a unique opportunity to shape your career and make a tangible impact on our success.
Job Purpose:
Join our Quality Assurance (QA) team, where you’ll play a vital role in supporting our bioanalytical facility’s dedication to Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). As a Quality Assurance Auditor, you’ll monitor studies, procedures, and reports, ensuring they meet rigorous GLP and GCP requirements, and provide expert guidance on quality and compliance issues.
Main Responsibilities:
*Maintain the Quality Assurance (QA) work program and oversee all QA activities to ensure regulatory compliance with GLP and GCP standards.
*Support Test Facility Management (TFM) by assisting with external inspections (e.g., MHRA GLP/GCP inspectorate, sponsors), ensuring courteous interactions, professional hosting, reasonable access, and the provision of accurate information.
*Provide responsive and proactive advice on quality, compliance, and regulatory matters, assisting TFM in upholding a robust compliance program.
*Deliver comprehensive GLP and GCP training to staff to foster consistent quality standards and ensure that Standard Operating Procedures (SOPs) align with regulatory requirements.
*Perform timely study plan, facility, study, process, data, and report audits, flagging any findings that may impact study integrity or facility compliance to Project Leaders, Study Directors, and Principal Investigators.
*Audit computer validation activities, ensuring validation documentation meets regulatory standards, and perform third-party supplier audits to assess and monitor their quality practices.
*Conduct inspections of study procedures, laboratory processes, and facilities, working closely with staff across all levels to uphold compliance standards.
*Maintain up-to-date knowledge of global GLP and GCP regulatory guidance, communicate effectively within the team, and stay informed about industry developments relevant to QA practices.
Qualifications and Experience:
*A degree in Life Sciences or chemistry related subject.
*Minimum of 2 years of experience auditing in a relevant or relatable quality standard (GLP, GCP. GMP, ISO)
*An eye for detail and the determination to complete tasks to a high standard within tight deadlines.
*Good decision making, negotiating, organisational and problem-solving skills.
*Ability to work under minimal supervision
Skills and Competencies:
Excellent computer literacy and competent in Microsoft office applications Outlook, Powerpoint, Word, Excel.
Beneficial Requirements (not essential):
*Experience of working within a GLP Test Facility
*Knowledge of specific scientific software platforms
*Experience working in a regulatory bioanalytical laboratory
Why Join Us?
We offer a competitive remuneration package, including salary, holidays, and benefits. If you’re ready to advance your career in a dynamic, supportive environment, we encourage you to apply and join us on our journey to excellence.
In addition, we offer the following:
*Social events & end of year function
*Family friendly leave for sick, paternity, maternity and parental
*Regular communication and engagement through BambooHR announcements and Town Hall meetings
*Regular employee engagement surveys
*Statutory/Public Holidays – flexible to be taken when chosen or on the actual public holiday (subject to management approval).
*Locally applied benefits per country, including annual leave and competitive pension contributions.
*Training and Development opportunities
*Annual Inflationary increases to salary (subject to budget and inflation)
*Strong applicant tracking system for recruitment and ensuring the onboarding process is an enjoyable experience for all new employees.
PLEASE ENSURE THAT YOUR CV/RESUME IS SUMBITTED IN ENGLISH.
We’re looking for a detail-oriented professional who can identify areas for improvement and support our compliance program, helping to uphold our commitment to excellence and innovation. With our rapid growth, this is a unique opportunity to shape your career and make a tangible impact on our success.
Job Purpose:
Join our Quality Assurance (QA) team, where you’ll play a vital role in supporting our bioanalytical facility’s dedication to Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). As a Quality Assurance Auditor, you’ll monitor studies, procedures, and reports, ensuring they meet rigorous GLP and GCP requirements, and provide expert guidance on quality and compliance issues.
Main Responsibilities:
*Maintain the Quality Assurance (QA) work program and oversee all QA activities to ensure regulatory compliance with GLP and GCP standards.
*Support Test Facility Management (TFM) by assisting with external inspections (e.g., MHRA GLP/GCP inspectorate, sponsors), ensuring courteous interactions, professional hosting, reasonable access, and the provision of accurate information.
*Provide responsive and proactive advice on quality, compliance, and regulatory matters, assisting TFM in upholding a robust compliance program.
*Deliver comprehensive GLP and GCP training to staff to foster consistent quality standards and ensure that Standard Operating Procedures (SOPs) align with regulatory requirements.
*Perform timely study plan, facility, study, process, data, and report audits, flagging any findings that may impact study integrity or facility compliance to Project Leaders, Study Directors, and Principal Investigators.
*Audit computer validation activities, ensuring validation documentation meets regulatory standards, and perform third-party supplier audits to assess and monitor their quality practices.
*Conduct inspections of study procedures, laboratory processes, and facilities, working closely with staff across all levels to uphold compliance standards.
*Maintain up-to-date knowledge of global GLP and GCP regulatory guidance, communicate effectively within the team, and stay informed about industry developments relevant to QA practices.
Qualifications and Experience:
*A degree in Life Sciences or chemistry related subject.
*Minimum of 2 years of experience auditing in a relevant or relatable quality standard (GLP, GCP. GMP, ISO)
*An eye for detail and the determination to complete tasks to a high standard within tight deadlines.
*Good decision making, negotiating, organisational and problem-solving skills.
*Ability to work under minimal supervision
Skills and Competencies:
Excellent computer literacy and competent in Microsoft office applications Outlook, Powerpoint, Word, Excel.
Beneficial Requirements (not essential):
*Experience of working within a GLP Test Facility
*Knowledge of specific scientific software platforms
*Experience working in a regulatory bioanalytical laboratory
Why Join Us?
We offer a competitive remuneration package, including salary, holidays, and benefits. If you’re ready to advance your career in a dynamic, supportive environment, we encourage you to apply and join us on our journey to excellence.
In addition, we offer the following:
*Social events & end of year function
*Family friendly leave for sick, paternity, maternity and parental
*Regular communication and engagement through BambooHR announcements and Town Hall meetings
*Regular employee engagement surveys
*Statutory/Public Holidays – flexible to be taken when chosen or on the actual public holiday (subject to management approval).
*Locally applied benefits per country, including annual leave and competitive pension contributions.
*Training and Development opportunities
*Annual Inflationary increases to salary (subject to budget and inflation)
*Strong applicant tracking system for recruitment and ensuring the onboarding process is an enjoyable experience for all new employees.
PLEASE ENSURE THAT YOUR CV/RESUME IS SUMBITTED IN ENGLISH.